MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 1998-05-19 for MEDCOMP 5 1/2" FEMORAL CATHETER MCF55 manufactured by Medcomp.
[96489]
Catheter broke inside the pt and was extracted with a surgical operation without consequences.
Patient Sequence No: 1, Text Type: D, B5
[7787598]
The customer returned only the lumen half of the catheter. The lumen portion of the catheter was forwarded to the mfr for evaluation and comment. The results of their investigation are inconclusive. The mfr states that the cause for failure is indeterminate, dut to the fact that the whole catheter was not returned to medcomp by the foreign customer. The part not returned would have made it possible to evaluate the failure mode.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518902-1998-00072 |
| MDR Report Key | 168655 |
| Report Source | 01,08 |
| Date Received | 1998-05-19 |
| Date of Report | 1998-04-20 |
| Date of Event | 1998-04-01 |
| Date Facility Aware | 1998-04-01 |
| Report Date | 1998-05-19 |
| Date Mfgr Received | 1998-04-20 |
| Date Added to Maude | 1998-05-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDCOMP 5 1/2" FEMORAL CATHETER |
| Generic Name | HEMODIALYSIS CATHETER |
| Product Code | LFK |
| Date Received | 1998-05-19 |
| Returned To Mfg | 1998-04-17 |
| Model Number | NA |
| Catalog Number | MCF55 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 164069 |
| Manufacturer | MEDCOMP |
| Manufacturer Address | 1499 DELP DR. HARLEYSVILLE PA 19438 US |
| Baseline Brand Name | 5 1/2" FEMORAL VEIN CATHETER |
| Baseline Generic Name | FEMORAL VEIN CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | MCF55 |
| Baseline ID | NA |
| Baseline Device Family | MEDCOMP SINGLE LUMEN HEMO-CATH |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K801967 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1998-05-19 |